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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, body composition
510(k) Number K040978
Device Name TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE
Applicant
TANITA CORP. OF AMERICA
2625 CLEARBROOK DR.
ARLINGTON HGTS.,  IL  60005
Applicant Contact RHODA L VALERA
Correspondent
UNDERWRITERS LABORATORIES, INC.
333 PFINGSTEN RD.
NORTHBROOK,  IL  60062
Correspondent Contact CHANTEL CARSON
Regulation Number870.2770
Classification Product Code
MNW  
Date Received04/15/2004
Decision Date 07/22/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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